Propulsid

"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.

Propulsid

Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)

WARNING

Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking cisapride. Many of these patients also took drugs expected to increase cisapride blood levels by inhibiting the cytochrome P450 3A4 enzymes that metabolize cisapride. These drugs include clarithromycin, erythromycin, troleandomycin, nefazodone, fluconazole, itraconazole, ketoconazole, indinavir, and ritonavir. Some of these events have been fatal. Cisapride is contraindicated in patients taking any of these drugs. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DRUG INTERACTIONS.)

QT prolongation, torsades de pointes (cisapride removed from us market) (sometimes with syncope), cardiac arrest, and sudden death have been reported in patients taking cisapride without the above-mentioned contraindicated drugs. Most patients had disorders that may have predisposed them to arrhythmias with cisapride. Cisapride is contraindicated for those patients with: history of prolonged electrocardiographic QT intervals or known family history of congenital long QT syndrome; renal failure; history of ventricular arrhythmias, ischemic heart disease, and congestive heart failure; clinically significant bradycardia; uncorrected electrolyte disorders (hypokalemia, hypomagnesemia); respiratory failure; and concomitant medications known to prolong the QT interval and increase the risk of arrhythmia, such as certain antiarrhythmics, including those of Class 1A (such as quinidine and procainamide) and Class III (such as sotalol); tricyclic antidepressants (such as amitriptyline); certain tetracyclic antidepressants (such as maprotiline); certain antipsychotic medications (such as certain phenothiazines and sertindole); astemizole, bepridil, sparfloxacin, and terodiline. (The preceding lists of drugs are not comprehensive.)

Recommended doses of cisapride should not be exceeded.

DRUG DESCRIPTION

Propulsid (cisapride removed from us market) tablets and suspension contain cisapride as the monohydrate, which is an oral gastrointestinal agent chemically designated as (±)-cis-4-amino-5-chloro-N-[1-[3-(4-fluorophenoxy) propyl]-3-methoxy-4-piperidinyl]-2-methoxybenzamide monohydrate. Its empirical formula is C23H29ClFN3O4·H2O. The molecular weight is 483.97.

Cisapride as the monohydrate is a white to slightly beige odorless powder. It is practically insoluble in water, sparingly soluble in methanol, and soluble in acetone. Each 1.04 mg of cisapride as the monohydrate is equivalent to one mg of cisapride.

Propulsid (cisapride removed from us market) is available for oral use in tablets containing cisapride as the monohydrate equivalent to 10 mg or 20 mg of cisapride and as a suspension containing the equivalent of 1 mg/ml of cisapride. The inactive ingredients in the tablets are colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone, and starch (corn). The 20 mg tablets also contain FD&C blue no. 2 aluminum lake. The inactive ingredients in the suspension are hydroxypropyl methylcellulose, methylparaben, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 20, propylparaben, sodium chloride, sorbitol, and water. The 1 mg/ml suspension also contains artificial cherry cream flavor and FD&C red no. 40.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.